The recent push to develop COVID-19 vaccines as quickly as possible revealed the continuing need to include diverse populations in all clinical trials. Without full representation, confidence in science and the healthcare system can take a hit.
Planning for richly diverse enrollment starts early in the process with the clinical trial design and follows immediately with enrollment and communication plans. After defining those most likely to benefit from the trial therapy and asking why they will be interested, the next steps include determining how to locate these populations and how to best reach them. We like to think of this as a three-phase process:
- Get to know your target audience.
- Develop your language access plan.
- Optimize community engagement.
1. Get to know your target audience.
Every group of people has its own historical and cultural underpinnings that guide their ways of operating, their own mythos, and their own points of access. Market research can showcase the influencers who drive the pulse of a community which, in turn, helps form strategies that can effectively reach the community.
Research on the therapeutic treatment, along with subsequent market research on the audience, contribute to developing this cultural awareness. Community engagement helps identify nuance and sensitivities that lead to messaging and outreach strategies that better resonate. Learning about the culture may increase your sensitivity to medical jargon, which could have a negative effect on the target audience. Proximity to the community also has the benefit of pitching interactions at a more personal level, which could aid the recruitment process.
After identifying the “who” of the target audience for the therapeutic trial, the next steps are to locate the cultural touchpoints of “why, what, when, and how.” Answering these questions creates a well-developed enrollment strategy. This should include market research and conversations with members of the communities to steer research toward optimal engagement with each community. In the end, this cultural understanding supports the formation of inclusive strategies.
2. Develop your language access plan.
It’s a good idea to incorporate language access planning early in the process, even during study design. Strategies should also include the production of printed collateral to boost recruitment. Remember that informed consent must be presented in a “language understandable to the [research] subject,” so the translation is critical.
Depending on the risk involved, translations may be reviewed for accuracy by a language-savvy member of the Internal Review Board (IRB), or such a review may need to be verified by an outside language expert. It’s important to plan for long lead times for the creation of messaging, materials, translation, and review into the required languages.
In addition to the typical enrollment strategy elements, which include locating the population centers, gathering lists, and locating social media and paid media opportunities, you must also workshop the messaging in a culturally appropriate way.
When developing your culturally diverse enrollment strategy, you will need to prepare patient recruiting messaging in a variety of formats that correspond to segmentations within the community. For example, younger community members might communicate through social media channels while older community members respond to traditional paid media such as broadcast advertising. In another example proving the benefit of community-level thinking, senior adults living in multigenerational houses may be reached by strategies that connect with their grown children, utilizing several communication channels. This enrollment strategy appreciates that grown children can have significant influence over the healthcare of their aging parents.
In each case, messaging must adhere to the ethical guidelines set forth by the IRB and present balanced information, including no implication of favorable outcomes or other benefits beyond what the consent document says. It is assumed the IRB will have the final say over the messaging as well as the potential interactive elements of social media. Naturally, these messages resonate best when translated and localized for each target audience.
Successful enrollment strategies will also focus on the retention of connections. These relationships promote clinical trial follow-up and may help with subsequent clinical trials.
3. Optimize community engagement.
Delivering messages in a community’s native language is key to successful engagement. Studies show that hearing and reading content in a mother tongue carries an emotional impact that is unrivaled by messaging delivered in a second language. Engaging potential trial participants in the community using their native language is a recommended ongoing practice. From the beginning of the trial, educational materials should be available in localized languages for each group.
Along with adapting messages and materials to the group’s preferred language, hiring translators and bilingual liaisons contributes to winning cultural trust on a community level. This can help IRBs and researchers grapple with localizing information for defined target audiences (under-enrollment of diverse populations starts with a lack of information about research opportunities and explanatory documents are “not provided in a language or at a health literacy level that is appropriate”). Care coordination programs with these elements (after clinical trial enrollment) can boost engagement in healthcare settings by pairing interpreters with participants who have limited English proficiency (LEP). These programs can also improve health literacy in the target community and dispel misconceptions and biases about healthcare procedures, treatments, and follow-ups.
In addition, planning for language access opens an opportunity for accurate and thorough ongoing data collection. Such planning might include collecting information on the patient groups’ primary languages for the later provision of language-appropriate services. Data collection over time (preferably over years) yields a better understanding of the target community’s health status and quality of life.
Effective community engagement and enrollment strategies will improve health outcomes in our culturally and linguistically diverse populations. Incorporating these solutions in your clinical trials will help research teams enroll and retain diverse populations, improving representation and health equity.
Keith Kennedy has more than 12 years in the language solutions space, focused on localization strategy for his partners. For the past eight years, his focus has been the highly regulated industries of Life Sciences and Healthcare. Currently Vice President of Sales at United Language Group, he leads a team of dedicated, humble, and expert Business Developers and Account Managers tasked with building true relationships forged in collaboration, integrity, and mutual success.
